A Group Senior Director, Respiratory Clinical Development
is sought to provide clinical and scientific support for potentially additional and established indications for the IL5 portfolio and emerging indications for other early and late-stage assets in the Respiratory
portfolio. As Senior Clinical Development Director, you will lead important new initiatives in the aIL-5 biologic space. You will work with project teams to plan and assure delivery of clinical research and development activities. You will work late development teams to plan clinical development programs and facilitate close collaboration between Research and Development. You will have direct line management responsibilities and will also lead senior clinicians and clinical scientists in a matrix role. Job purpose and key responsibilities
Why you? Basic Qualifications
- Lead matrix team of senior clinicians and clinical scientists with responsibilities for various clinical development programs. Support technical and leadership development of Clinical Sciences staff via direct line management, mentoring and coaching.
- Identify and highlight acceleration, innovation, and transformational opportunities where projects can offer highly significant benefit to patients.
- Champion implementation of innovative methods and processes within clinical development and gain stakeholder support; encourage others to think differently and come up with business solutions.Oversee the strategic management of the Integrated Evidence Plan (IEP), including oversight of the Clinical Development Plan (CDP) and its component clinical trials for those assets in development under your leadership. Provide strategic leadership in designing the CDPs and IEPs, and then, for example in assuring that clinical study protocol designs are aligned with the IEP and CDP, and consider the scientific rationale, regulatory requirements, product development plan and commercial goals.
- Develop and maintain relationships with corporate counterparts in Commercial, Early Development, Research, Regulatory Affairs, Clinical Operations, Biostatistics, and other groups.
- Oversee clinical aspects of Business Development activities, including due diligence projects.
- Serve as a clinical point of contact for senior management and senior level matrix teams.
- Interface with and influence a range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators) to deliver clinical programs that align to business strategy and address patient needs
- Identify and highlight acceleration and value-finding opportunities where projects can offer highly significant benefit to patients.
- Assess risk/benefit at the study and/or project level. Take action to mitigate risk where appropriate.
- Make substantial contributions to regulatory interactions, including briefing documents, presentations, submission documents, and responses to questions.
- MD or PhD or PharmD degree
- Significant industry experience in clinical drug development, including leading preparation of submission documents to regulatory authorities for approval of a new drug or indication, preferably in Respiratory, Immunology, or Infectious Disease.
- Experience with leading and driving clinical development for an asset and/or indication. Proven record of delivery of clinical trials and projects. Knowledge of clinical research methodology and principles of biostatistics to facilitate accelerated. innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules
- Line management, coaching, mentoring and development experience. Experience leading line and matrix teams with a track record of inspiring and motivating high performance
- Strong leadership skills, with proven ability to inspire high performance from cross-functional teams
- Track record of building and maintaining strong relationships with internal and external stakeholders
- Robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements
- Solid understanding of needs and priorities of regulators, payers, and prescribers in relevant market(s)
Post-graduate qualification valuable Why GSK?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in ConsumerHealthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significantchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
NewGSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; anda new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as anew GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture thatisambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership of goalsand support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at this excitingmoment in our journey. Join our challenge to get Ahead Together. #LI_GSK #LI-Hybrid #ClinicalSciences
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